Pelvital USA, Inc.
FDA Regulatory Profile
Pelvital USA, Inc. appears in FDA public data with 0 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 1, 2024.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240805 | Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) | August 1, 2024 |
| K233362 | Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) | December 29, 2023 |
| K212655 | Flyte | September 21, 2021 |
| K210764 | Flyte | April 13, 2021 |
| K200409 | Pelvital System | July 10, 2020 |